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Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment

The University of Texas M.D. Anderson Cancer Center, Houston, TX

To the Editor:

On behalf of the study investigators, I would like to communicate results of a US Food and Drug Administration–requested sensitivity analysis of progression-free survival (PFS) from a phase III study of ixabepilone plus capecitabine versus capecitabine alone in patients with metastatic breast cancer. This analysis provides evidence for additional clinical benefit of ixabepilone plus capecitabine not previously included in a report¹ published in the November 20, 2007, issue of the Journal of Clinical Oncology.

The report described efficacy and safety results for 752 patients with metastatic breast cancer resistant to or previously treated with an anthracycline, and resistant to taxanes. Median PFS was significantly prolonged (P = .0003) for patients treated with the combination of ixabepilone plus capecitabine versus capecitabine alone: 5.8 months (95% CI, 5.45 to 6.97 months) versus 4.2 months (95% CI, 3.81 to 4.50 months). The hazard ratio (0.75; 95% CI, 0.64 to 0.88; P = .0003) indicated a 25% reduction in the risk of disease progression.

In the original analysis of PFS, patients were counted as having experienced disease progression regardless of whether subsequent therapy was initiated before the date of progression. After submission of the article, the US Food and Drug Administration requested a sensitivity analysis of these PFS data. Patients who received subsequent therapy before the date of progression were censored for PFS at the last tumor assessment date, before the start of subsequent therapy. This analysis demonstrated significantly prolonged PFS in patients in the combination arm. Median PFS was 5.7 months (95% CI, 4.8 to 6.7 months) for ixabepilone plus capecitabine, and 4.1 months (95% CI, 3.1 to 4.3 months) for capecitabine alone. The hazard ratio, 0.69 (95% CI, 0.58 to 0.83; P < .0001), indicated a 31% reduction in the risk of disease progression. These data are reflected in the current United States labeling for ixabepilone.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCE

1. Thomas ES, Gomez HL, Li RK, et al: Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25:5210-5217, 2007[Abstract/Free Full Text]

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